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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
ClotriMazole IMpurity A ClotriMazole IMpurity A 23593-71-7 C22H17ClN2
9-Nitrominocycline 9-Nitrominocycline 149934-16-7 C23H26N4O9
N-(3,5-DiMethyladaMantan-1-yl)forMaMide N-(3,5-DiMethyladaMantan-1-yl)forMaMide 351329-88-9 C13H21NO
N-(Methylsulfonyl)-4'-nitro-2'-phenoxyMethanesulfonanilide N-(Methylsulfonyl)-4'-nitro-2'-phenoxyMethanesulfonanilide 51765-72-1 C14H14N2O7S2
Olanzapine ThioacetoxyMethylidene IMpurity

Discontinued Olanzapine ThioacetoxyMethylidene IMpurity Discontinued 1320360-87-9 C17H20N4O2S
1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1385018-57-4 C26H27NO2
1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1385018-57-4 C26H27NO2
24R-Calcipotriol 24R-Calcipotriol 112827-99-3 C27H40O3
Methotrexate IMpurity C Methotrexate IMpurity C
Paroxetine EP IMpurity G Paroxetine EP IMpurity G 69675-10-1 C12H14FN
Itraconazole impurity C Itraconazole impurity C
1-cyclopropyl-8-ethoxy-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 1-cyclopropyl-8-ethoxy-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 143158-55-8 C15H13F2NO4
3-((3S,4R)-4-Methyl-3-(Methyl(7H-pyrrolo[2,3-d]pyriMidin-4-yl)aMino)piperidin-1-yl)-3-oxopropanenitrile 3-((3S,4R)-4-Methyl-3-(Methyl(7H-pyrrolo[2,3-d]pyriMidin-4-yl)aMino)piperidin-1-yl)-3-oxopropanenitrile 1092578-48-7 C16H20N6O
4-aMino-5-chloro-2,3-dihydro-N-4-piperidinyl-7-BenzofurancarboxaMide 4-aMino-5-chloro-2,3-dihydro-N-4-piperidinyl-7-BenzofurancarboxaMide 137211-64-4 C14H18ClN3O2
2-[3-Carboxy-4-(2-Methylpropoxy)phenyl]-4-Methyl-5-thiazolecarboxylic Acid 2-[3-Carboxy-4-(2-Methylpropoxy)phenyl]-4-Methyl-5-thiazolecarboxylic Acid 1239233-87-4 C16H17NO5S
4-(2-Methylpropyl)benzeneethanol 4-(2-Methylpropyl)benzeneethanol 36039-35-7 C12H18O
Dasatinib DiMeric IMpurity Dasatinib DiMeric IMpurity 910297-61-9 C36H34Cl2N12O2S2
Decarboxy Fexofenadine Decarboxy Fexofenadine 185066-37-9 C31H39NO2
(1S,3S,4R)-Entecavir (1S,3S,4R)-Entecavir 1367369-79-6 C12H15N5O3
Platycodin D2 Platycodin D2 66663-90-9 C63H102O33
Prasugrel Impurity III Prasugrel Impurity III 1391194-50-5 C20H20FNO3S
2-(4-(6-((5-((2-chloro-6-Methylphenyl)carbaMoyl)thiazol-2-yl)aMino)-2-MethylpyriMidin-4-yl)piperazin-1-yl)ethyl acetate 2-(4-(6-((5-((2-chloro-6-Methylphenyl)carbaMoyl)thiazol-2-yl)aMino)-2-MethylpyriMidin-4-yl)piperazin-1-yl)ethyl acetate 1245157-85-0 C24H28ClN7O3S
Ebastine IMpurity F Ebastine IMpurity F 1429071-63-5 C32H39NO3
N-((S)-1-(((R)-1-Hydroxy-3-Methylbutyl)aMino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide N-((S)-1-(((R)-1-Hydroxy-3-Methylbutyl)aMino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide 289472-78-2 C19H24N4O3
AMoxicillin iMpurity J AMoxicillin iMpurity J 2088960-43-2 C32H38N6O10S2
Azilsartan iMpurity O Azilsartan iMpurity O 2171316-29-1 C23H19N3O4
cefoxitin iMpurity C cefoxitin iMpurity C
3-((3R,4R)-3-((2-chloro-7H-pyrrolo[2,3-d]pyriMidin-4-yl)(Methyl)aMino)-4-Methylpiperidin-1-yl)-3-oxopropanenitrile 3-((3R,4R)-3-((2-chloro-7H-pyrrolo[2,3-d]pyriMidin-4-yl)(Methyl)aMino)-4-Methylpiperidin-1-yl)-3-oxopropanenitrile 1616761-00-2 C16H19ClN6O
Aprepitant iMpurity Aprepitant iMpurity 96730-04-0 C13H22NO4P
Bendamustine Deschloro Dimer Impurity Bendamustine Deschloro Dimer Impurity 1391052-61-1 C32H44N6O7
Benzenepropanoic acid, β-aMino-α-hydroxy-, Methyl ester, (αR,βR)- Benzenepropanoic acid, β-aMino-α-hydroxy-, Methyl ester, (αR,βR)- 157722-44-6 C10H13NO3
Benzenebutanoicacid,b-aMino-2,4,5-trifluoro-,Methylester,(bR)- Benzenebutanoicacid,b-aMino-2,4,5-trifluoro-,Methylester,(bR)- 881995-69-3 C11H12F3NO2
Avanafil iMpurity 2 Avanafil iMpurity 2
Bisoprolol IMpurity Bisoprolol IMpurity 2226263-67-6 C18H31NO4
Decitabine iMpurity 5 Decitabine iMpurity 5
Erlotinib iMpurity 3 Erlotinib iMpurity 3 328528-74-1 C20H22BrN3O4
LevetiracetaM IMpurity 3 LevetiracetaM IMpurity 3 1543353-92-9 C8H15NO4
Sofosbuvir IMpurity Sofosbuvir IMpurity
(3R,4R,5R)-4-(1-Ethylpropoxy)-3-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester (3R,4R,5R)-4-(1-Ethylpropoxy)-3-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester 204254-94-4 C15H26O7S
9,11-Anhydrobudesonide 9,11-Anhydrobudesonide 313474-58-7 C25H32O5
2-(4-((4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)acetic acid 2-(4-((4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)acetic acid 113740-61-7 C19H21ClN2O2
EveroliMus-d4 EveroliMus-d4 1338452-54-2 C53H79D4NO14
(2R,3R,4R,5R)-5-(4-benzaMido-2-oxopyriMidin-1(2H)-yl)-2-((benzoyloxy)Methyl)-4-chloro-4-Methyltetrahydrofuran-3-yl benzoate (2R,3R,4R,5R)-5-(4-benzaMido-2-oxopyriMidin-1(2H)-yl)-2-((benzoyloxy)Methyl)-4-chloro-4-Methyltetrahydrofuran-3-yl benzoate 1496551-70-2 C31H26ClN3O7
1-((2R,3S,4R,5R)-3,4-dihydroxy-5-(hydroxyMethyl)-3-Methyltetrahydrofuran-2-yl)pyriMidine-2,4(1H,3H)-dione 1-((2R,3S,4R,5R)-3,4-dihydroxy-5-(hydroxyMethyl)-3-Methyltetrahydrofuran-2-yl)pyriMidine-2,4(1H,3H)-dione 114262-49-6 C10H14N2O6
4-(4-(3-(4-chloro-3-(trifluoroMethyl)phenyl)ureido)-3-fluorophenoxy)-2-(MethylcarbaMoyl)pyridine 1-oxide 4-(4-(3-(4-chloro-3-(trifluoroMethyl)phenyl)ureido)-3-fluorophenoxy)-2-(MethylcarbaMoyl)pyridine 1-oxide 835621-11-9 C21H15ClF4N4O4
D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-[[4-[4-[4-[1-(1-ethylpropyl)-1,5-dihydro-5-oxo-4H-1,2,4-triazol-4-yl]phenyl]-1-piperazinyl]phenoxy]Methyl]-1-(1H-1,2,4-triazol-1-yl)- D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-[[4-[4-[4-[1-(1-ethylpropyl)-1,5-dihydro-5-oxo-4H-1,2,4-triazol-4-yl]phenyl]-1-piperazinyl]phenoxy]Methyl]-1-(1H-1,2,4-triazol-1-yl)- 161532-65-6 C37H42F2N8O3
1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan-1-one 1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan-1-one 186521-85-7 C15H19ClO
NSC 351869 NSC 351869 31350-27-3 C14H14N2O4
4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-iodo-2-methoxybenzamide 4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-iodo-2-methoxybenzamide 176849-91-5 C15H22IN3O2
N,N'-Vis[2-(3,4-dimethoxyphenyl)ethyl]-N,N'-dimethyl-1,3-propanediamine dihydrochloride N,N'-Vis[2-(3,4-dimethoxyphenyl)ethyl]-N,N'-dimethyl-1,3-propanediamine dihydrochloride 63434-11-7 C25H39ClN2O4
2-Bromo-3'-chloropropiophenone 2-Bromo-3'-chloropropiophenone 34911-51-8 C9H8BrClO
(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid hydrochloride (2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid hydrochloride 1038924-71-8 C18H22ClNO2
(3R,4S,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)-2-methoxyoxane-3,4,5-triol (3R,4S,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)-2-methoxyoxane-3,4,5-triol 915095-96-4 C24H29ClO8
Doxorubicin Imp B HBr salt Doxorubicin Imp B HBr salt 148218-14-8 C29H35Br2NO11
Doxofylline iMpurity Doxofylline iMpurity 254760-82-2 C11H16N4O4
forMoterol iMpurity forMoterol iMpurity
LevetiracetaM IMpurity 4 LevetiracetaM IMpurity 4 1342229-32-6 C10H19NO4
cinacalcet iMpurity 4 cinacalcet iMpurity 4 955373-56-5 C22H20F3N
Acyclovir IMpurity J Acyclovir IMpurity J
AzithroMycin IMpurity K AzithroMycin IMpurity K
AztreonaM IMpurity F AztreonaM IMpurity F 102579-57-7 C15H21N5O8S2
BendaMustine Dideschloroethyl IMpurity BendaMustine Dideschloroethyl IMpurity
BroMocriptine IMpurity F BroMocriptine IMpurity F 82773-21-5 C32H40BrN5O5
Cephalexin IMpurity J Cephalexin IMpurity J C16H17N3O4S
Cetirizine IMpurity (4-Chlorobenzophenone) Cetirizine IMpurity (4-Chlorobenzophenone) 2724877-99-8 C21H25ClN2O3
Dasatinib IMpurity 3 Dasatinib IMpurity 3
Deferasirox IMpurity 2 Deferasirox IMpurity 2
Desvenlafaxine (O-DesMethyl Venlafaxine) FuMarate Desvenlafaxine (O-DesMethyl Venlafaxine) FuMarate 93414-04-1 C20H29NO6
EzetiMibe Dehydoxy IMpurity EzetiMibe Dehydoxy IMpurity 204589-58-2 C24H21F2NO2
Flurbiprofen IMpurity E Flurbiprofen IMpurity E
Levocarnitine IMpurity D Levocarnitine IMpurity D
Montelukast EP IMpurity E Montelukast EP IMpurity E 1187586-58-8 C41H46ClNO5S2
Prasugrel IMpurity 6 Prasugrel IMpurity 6
RebaMipide 2-Chloro IMpurity RebaMipide 2-Chloro IMpurity 90098-06-9 C19H15ClN2O4
Ribavirin IMp. F (EP) Ribavirin IMp. F (EP)
RocuroniuM BroMide IMpurity 17 RocuroniuM BroMide IMpurity 17
SalMeterol IMpurity D SalMeterol IMpurity D C25H37NO4
SulbactaM IMpurity A SulbactaM IMpurity A
Tigecycline Metabolite M6 (9-AniMoMinocycline) Tigecycline Metabolite M6 (9-AniMoMinocycline) 149934-19-0 C23H28N4O7
VerapaMil IMpurity G VerapaMil IMpurity G C27H38N2O4
EthanediaMide  iMpurity D EthanediaMide iMpurity D 480452-36-6 C21H30ClN5O5
N-(4-(2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine-6-carbonyl)phenyl)-[1,1'-biphenyl]-2-carboxaMide N-(4-(2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine-6-carbonyl)phenyl)-[1,1'-biphenyl]-2-carboxaMide 168626-93-5 C32H25N3O3
1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide 1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide C24H22ClN5O3
Methyl (4-Methylpiperidin-3-yl)carbaMate Methyl (4-Methylpiperidin-3-yl)carbaMate 1204176-45-3 C8H16N2O2
(R)-3-(4-(5-broMo-2-chlorobenzyl)phenoxy)tetrahydrofuran (R)-3-(4-(5-broMo-2-chlorobenzyl)phenoxy)tetrahydrofuran 915095-90-8 C17H16BrClO2
(2S,3R,4S,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-tetrahydro-6-(hydroxyMethyl)-2-Methoxy-2H-pyran-3,4,5-triol (2S,3R,4S,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-tetrahydro-6-(hydroxyMethyl)-2-Methoxy-2H-pyran-3,4,5-triol 1358581-37-9 C25H27FO6S
Levocarnitine iMpurity Levocarnitine iMpurity 6490-20-6 C7H17ClN2O2
3-Hydroxy-4-Methyl-2(5H)-thiophenone 3-Hydroxy-4-Methyl-2(5H)-thiophenone 34876-35-2 C5H6O2S
(1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-Hexahydro-3,7-diMethyl-8-[2-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl Ester (2Z)-2-Methyl-2-butenoic Acid (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-Hexahydro-3,7-diMethyl-8-[2-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl Ester (2Z)-2-Methyl-2-butenoic Acid 1048973-04-1 C24H34O5
(6α)-17,21-Dihydroxy-6-Methylpregna-1,4,9(11)-triene-3,20-dione (6α)-17,21-Dihydroxy-6-Methylpregna-1,4,9(11)-triene-3,20-dione 93269-35-3 C22H28O4
[N(Z)]-N-(3,5-DiMethyl-2(3H)-thiazolylidene)-4-hydroxy-2-Methyl-2H-1,2-benzothiazine-3-carboxaMide 1,1-Dioxide [N(Z)]-N-(3,5-DiMethyl-2(3H)-thiazolylidene)-4-hydroxy-2-Methyl-2H-1,2-benzothiazine-3-carboxaMide 1,1-Dioxide 1262333-25-4 C15H15N3O4S2
Quetiapine Impurity E Quetiapine Impurity E 1371638-05-9 C40H44N6O2S2
(E)-2-(6-(methoxycarbonyl)-2-oxoindolin-3-ylidene)-2-phenylacetic acid (E)-2-(6-(methoxycarbonyl)-2-oxoindolin-3-ylidene)-2-phenylacetic acid C18H13NO5
8-Epi-cyanocobalamin 8-Epi-cyanocobalamin 41325-63-7 C63H88CoN14O14P
Lamivudine Impurity 2 Lamivudine Impurity 2 200396-21-0 C18H27N3O4S
Lamivudine Impurity 1 Lamivudine Impurity 1 1235712-40-9 C8H11N3O4S
Moxifloxacin Related Impurity 3 Moxifloxacin Related Impurity 3
Bisoprolol EP Impurity Q Bisoprolol EP Impurity Q 1346604-00-9 C16H27NO4
Levofloxacin N-Oxide Levofloxacin N-Oxide 117678-37-2 C18H20FN3O5
Oseltamivir EP Impurity A Oseltamivir EP Impurity A 1391047-93-0 C14H24N2O4
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